Studying First Line Treatment of Chronic Myeloid Leukemia (CML) in a Real-world Setting
- Conditions
- Chronic Myeloid Leukemia
- Registration Number
- NCT01244750
- Lead Sponsor
- Bristol-Myers Squibb
- Brief Summary
The purpose of this study is to better understand the use of tyrosine kinase inhibitors (TKI) in patients newly diagnosed with CML and their quality of life in a real-world setting.
- Detailed Description
Time Perspective : Most patients are expected to be a mix of retrospective and prospective data collection. Patients can be enrolled after their study index date (retrospective component) and have to be followed until 5 years from study index date are complete (time between enrollment and 5 year follow-up is the prospective component)
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1494
-
Newly-diagnosed chronic phase chronic myeloid leukemia (CP-CML) patients who started their first-line Tyrosine Kinase Inhibitor (TKI) treatment on imatinib, dasatinib or nilotinib in accordance with the timelines below
-
18 years or older at time of of CP-CML diagnosis
a) Imatinib Cohorts
-
Patients who started their first-line Imatinib treatment between January 2, 2008 and September 30, 2010.Patients fitting this criterion are defined as retrospective Imatinib patients
-
Patients who started their first-line Imatinib treatment on or after October 1, 2010
b) Dasatinib Cohort
-
Patients who started their first-line Dasatinib treatment after the drug was approved in this indication
c) Nilotinib Cohort
-
Patients who started their first-line Nilotinib treatment after the drug was approved in this indication
-
Patients are also eligible when they have already switched to a subsequent therapy (TKI or other) at the time of enrollment, as long as their first-line and subsequent CML treatment information is available at site for data entry into the study Electronic Case Report Form (eCRF)
-
Receiving treatment at medical practice (eg. community-based, office-based, hospital-based, academic setting, oncology center)
- Patients who are participating in an interventional trial which may influence the management of their CML disease will be excluded
Discontinuation Criteria:
- Enrolled patients who join an interventional trial which may influence the management of their CML disease will be excluded at the time of entry into the interventional trial
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The rate of best response to therapy (i.e. hematologic, cytogenetic, molecular response) Every 6 months for a follow-up period of 5-years from study index date Results and dates of: all bone marrow aspirates, blood tests, cytogenetics, Polymerase Chain Reaction (PCR), Fluorescent In-Situ Hybridization (FISH), and Physical exam
The rate of discontinuation and treatment changes after initial TKI treatment Every 6 months for a follow-up period of 5-years from study index date Dates of switches in therapy from initial TKI treatment, Reasons for treatment discontinuation (i.e. side effects, mutations, etc.), Subsequent lines of CML treatments (start and stop dates)
The duration of initial TKI treatment 5-years from study index date Initiation of first-line TKI, (whether Dasatinib, Imatinib, Nilotinib)
The rate of Complete Cytogenetic Response 12 months The adherence to treatment Every 6 months for a follow-up period of 5-years from study index date Morisky Medication Adherence Scale - 8 Items is a validated self-reported measure of medication adherence.
- Secondary Outcome Measures
Name Time Method Impact of first-line treatment options on quality of life Every 6 months Questionnaires used for assessment:
Functional Assessment of Cancer Therapy - General (FACT-G), Cancer Therapy Satisfaction Questionnaire (CTSQ), MD Anderson Symptom Inventory - CML (MDASI-CML).Resource utilization associated with CML management Every 6 months To evaluate healthcare resource utilization, descriptive statistics will describe real-world disease monitoring patterns, frequency of testing, and resources used for disease management for each treatment cohort.
Non-hematologic side effects from treatment affecting patient quality of life and outcomes Every 6 months Treatment discontinuations and changes
Patient satisfaction with CML treatment Every 6 months Cancer Therapy Satisfaction Questionnaire (CTSQ)
Patterns of disease monitoring as observed in a real-world setting Every 6 months MD Anderson Symptom Inventory - CML (MDASI-CML) Questionnaire - disease-specific module of the MDASI7 which is a brief measure of severity and impact of cancer-related symptoms on daily function
Trial Locations
- Locations (142)
Northwest Alabama Cancer Center
🇺🇸Muscle Shoals, Alabama, United States
Arizona Oncology Associates, PC - HAL
🇺🇸Phoenix, Arizona, United States
Arizona Oncology Associates, PC - NAHOA
🇺🇸Sedona, Arizona, United States
Arizona Oncology Associates, PC - HOPE
🇺🇸Tucson, Arizona, United States
Genesis Cancer Center
🇺🇸Hot Springs National Park, Arkansas, United States
NEA Baptist Clinic
🇺🇸Jonesboro, Arkansas, United States
Little Rock Hematology Oncology Associates
🇺🇸Little Rock, Arkansas, United States
Pacific Cancer Medical Center, Inc
🇺🇸Anaheim, California, United States
Southwest Cancer Care Medical Group
🇺🇸Escondido, California, United States
Wilshire Oncology Medical Group, Inc
🇺🇸Glendora, California, United States
Scroll for more (132 remaining)Northwest Alabama Cancer Center🇺🇸Muscle Shoals, Alabama, United States